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    Summary
    EudraCT Number:2012-000987-11
    Sponsor's Protocol Code Number:2012/409
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-31
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2012-000987-11
    A.3Full title of the trial
    DEBIRI-TACE
    (DRUG ELUTING BEAD med IRINOTECAN-TRANS ARTERIEL CHEMO EMBOLIZATION)

    Intrahepatic chemoembolization with irinotecan-containing DC-BEADS combined with systemic chemotherapy and bevacizumab. A non-randomized, Phase II clinical trial, for the treatment of patients with the "liver-only" metastasis, from colorectal cancer, who are not candidates for the curative intended treatments at diagnosis.

    DEBIRI-TACE
    (DRUG ELUTING BEAD med IRINOTECAN-TRANS ARTERIEL CHEMO EMBOLIZATION)

    Intrahepatisk kemoembolisering med irinotecan holdige DC-BEADS sammen med systemisk kemoterapi og bevacizumab. Et ikke randomiseret fase II forsøg til behandling af patienter med ”liver-only” metastase-rende colorectal cancer der ikke er kandidater til kurativt intenderet lokal behandling ved diagnose.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Regional Chemotherapy with Intrahepatic Irinotecan Beads for patients with Livermetastatic Colorectal Cancer.
    Regionalkemoterapi med irinotecan perler i leveren til patienter med tyk-og endetarms kræft med spredning til leveren
    A.3.2Name or abbreviated title of the trial where available
    DEBIRI-TACE
    A.4.1Sponsor's protocol code number2012/409
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAnni Ravnbek Jensen
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTerumo Europe
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus Univercity Hospithal
    B.5.2Functional name of contact pointMartin Jensen
    B.5.3 Address:
    B.5.3.1Street AddressNorrebrogade 44
    B.5.3.2Town/ cityAarhus
    B.5.3.3Post code8800
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4540352369
    B.5.5Fax number+4578462550
    B.5.6E-mailmartin.jensen02@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Irinotecan
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Oncology Plc.
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIrinotecan
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrahepatic use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic colorectal cancer with metastasis confined to the liver
    Metastatisk colorectal cancer med metastaser isoleret til leveren.
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer that has spread only to liver
    Tyk- eller endetarms kræft der har spredt sig alene til leveren
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of drug eluting bead with irinotecan-trans arteriel chemoembolizatin, administered in combination with FOLFOX and bevacizumab, followed by standard treatment with FLIRI and bevacizumab in patients with liver-only metastatic CRC .
    At undersøge effekten af DEBIRI-TACE konkomitant med FOLFOX og bevacizumab, efter fulgt af standard behandling med FLIRI og bevacizumab hos patienter med liver only metastatisk CRC .
    E.2.2Secondary objectives of the trial






    Engelsk



    Dansk



    Tysk





    -To observe the peripheral concentration of irinotecan and its degradation products during DEBIRI-TACE and FILIRI treatments

    -To observe whether DEBIRI-TACE causes an angiogenesis-promoting effect by measuring specific biomarkers in serial blood samples and to correlate these biomarkers with clinical endpoints.

    -To assess tumor blood flow by means of serial dynamic imaging (CT perfusion), and to correlate this with the clinical endpoints.
    -At observere den perifere koncentration af irinotecan og dens nedbrydnings produkter under DEBIRI-TACE og FILIRI behandlinger

    -At observerer hvorvidt DEBIRI-TACE medføre en angiogenese fremmende effekt vurde-ret ved måling af specifikke biomarkører i serielle blodprøver og at korrelere disse biomarkører med de klinisk endepunkter.

    -At vurderer tumor-blodgennemstrømningen vha seriel dynamisk billeddannelse (CT-perfusion) og at korrelere dette med de kliniske endepunkter.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Informed consent
    -Age over 18 years
    -Performance status 0-1 and remaining life expectancy of> 3 months
    -Histologically proven adenocarcinoma from the colon or rectum
    -Either remove the primary tumor or primary tumor is deemed operable
    -Liver metastases where local treatment is not possible
    -The presence of liver metastases documented by contrast multiphase CT
    -Extrahepatic disease not detected
    -No chemo therapy for at least 6 months (adjuvant)
    -Liver involvement <50%
    -Neutrophils> 1.5 x 109 and platelets> 100 x 109, bilirubin <2.0 x ULN, INR <1.5
    -Creatinine clearance calculated by Cockcroft-Gault> 40 ml / min
    -INR <1.5
    -It is possible to implement DEBIRI-TACE













    -Informeret samtykke
    -Alder over 18 år
    -Performance status 0-1 og forventet restlevetid >3 måneder
    -Histologisk dokumenteret adenocarcinom udgået fra colon eller rectum
    -Enten fjernet primær tumor, eller at primær tumor er skønnet operabel
    -Levermetastaser hvor lokal behandling ikke er mulig
    -Tilstedeværelsen af levermetastaser skal være dokumenteret ved kontrast flerfase CT
    -Ekstrahepatisk sygdom kan ikke påvises
    -Ikke have modtaget kemo terapi i mindst 6 måneder (adjuverende)
    -Leverinvolvering < 50 %
    -Neutrofile granulocytter >1.5 x 109 og thrombocytter >100 x 109 , bilirubin <2.0 x øvre normal værdi, INR<1.5
    -Kreatinin-clearence beregnet i henhold til cockcroft-Gault > 40 ml/min
    -INR<1.5
    -Det er muligt at gennemføre DEBIRI-TACE
    E.4Principal exclusion criteria
    -Second malignancy except basal cell carcinoma and in situ carcinoma of the cervics uteri
    -Treatment with other experimental drugs or participation in other trials.
    -Pre-existing polyneuropathy more than Grade 1 (NCI CTC v. 3)
    -Other serious medical disease, cardiomyopathy> NYHA II, AMI where aggretions antiplatelet therapy is ongoing. Symptoms of angina pectoris.
    -Arterial thromboembolic events including transient ischemic attack, or myocardial infarction within 12 months.
    -Congenital bleeding diathesis or acquired coagulopathy
    -BMI> 40
    -Treatment with St. John's Wort, CYP3A-inducing anticonvulsants or ketoconazole.
    -Physical or mental illness that would prevent understanding or Compliance
    -Patients with uncontrolled infection
    -Pregnant or lactating women. In fertile women, this is done with a negative pregnancy test
    -Women of childbearing potential not using adequate contraception
    -Patients of linguistic, intellectual or cultural reasons do not fully understand the treatment concept and respond appropriately to complications and side effects
    -Sensitivity, to any or several of the known active agents, or adjuvants which form part of the intended treatment
    -Anden malign sygdom bortset fra basalcellekarcinom og karcinoma in situ cervics uteri
    -Behandling med anden forsøgsmedicin eller deltagelse i andre forsøg.
    -Præeksisterende polyneuropathi mere end grad 1 (NCI CTC v. 3)
    -Anden alvorlig medicinsk sygdom, kardiomyopati >NYHA II, AMI hvor antithrombocyt aggretions behandling pågår. Symptomer på angina pectoris.
    -Arterielle tromboemboliske hændelser inklusive transitoriske iskæmisk anfald og myokar-dieinfarkt indenfor 12 måneder.
    -Medfødt blødnings diatese eller erhvervet koagulationsdefekt
    -BMI >40
    -Pågående behandling med perikon, CYP3A-inducerende antikrampemidler eller ketoconazol.
    -Fysiske eller psykiske sygdomme, som kan forhindre forståelse eller kompliance
    -Patienter med ukontrolleret infektion
    -Gravide eller ammende kvinder. Hos fertile kvinder sikres dette med negativ graviditetstest
    -Fertile kvinder der ikke bruger sikker antikonception
    -Patienter som af sproglige, intellektuelle eller kulturelle grunde ikke fuldt ud vil kunne forstå behandlingskonceptet og reagere adækvat på komplikationer og bivirkninger
    -Overfølsomhed, overfor et ,eller flere af de kendte aktive stoffer, eller hjælpestoffer der indgår i den planlagte behandling
    E.5 End points
    E.5.1Primary end point(s)
    Frequency of surgical resection and / or RFA treatment.
    Frekvens af kirurgisk resektion og/eller RFA behandling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -6 Months after the last patient has completed the study the frequency of surgical resection and / or RFA treatment will be determined
    -6 måneder efter sidste patient har gennemført studiet opgøres frekvensen af kirurgisk resektion og/eller RFA behandling.

    E.5.2Secondary end point(s)
    -Response rate, as measured by RECIST 1.1
    -Response-duration
    -Time to progression of liver / extrahepatic,
    -1 And 5 year survival
    -The safety profile of the combination of DEBIRI-TACE, FOLFOX and bevacizumab
    -Responsrate målt ved RECIST 1.1
    -Respons-varighed
    -Tid til progression lever/ekstrahepatisk,
    -1 og 5 års overlevelse
    -Sikkerhedsprofilen for kombinationen af DEBIRI-TACE, FOLFOX og bevacizumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    -6 Months after the last patient has completed the study the safety profile vil be compiled.

    -12 Months after the last patient has completed treatment, 1 year survival will be determind.

    -60 Months after the last patient has gennmført treatment or last patient has died, respons duration, TTP, and 5 year survival will be determind
    -6 måneder efter sidste patient har gennemført studiet opgøres sikkerhedsprofilen.

    -12 måneder efter den sidste patient har gennemført behandling, opgøres 1 årsoverlevelse.

    -60 måneder efter sidste patient har gennmført behandling eller sidst patient er afgået ved døden, opgøres responsvarrighed, TTP, og 5 års overlevelse
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    60 months after last patient has completed the treatment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months78
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 50
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation GCP-enheden ved Århus Universitetshospital
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-04-01
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